Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy, safety and tolerability of an oral aripiprazole/escitalopram combination therapy in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder (MDD)

Summary: this will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral aripiprazole/escitalopram combination therapy in participants with mdd who have demonstrated an incomplete response to a prospective trial of escitalopram, and report a treatment history for the current mdd episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than escitalopram. an inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the massachusetts general hospital antidepressant treatment response questionnaire (atrq) and evaluated by the investigator as part of the participant's medical and psychiatric history. an adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the atrq.

the study will be organized as follows: * screening phase * single-blind prospective treatment phase * single-blind continuation phase (responder) or double-blind randomization phase (non-responder) * 30 day post treatment follow-up assigned interventions: * escitalopram monotherapy * aripiprazole/escitalopram combination therapy * aripiprazole monotherapy

Eligibility criteria:
inclusion criteria: * participants with a current diagnosis of a major depressive episode. the current depressive episode must be ≥ 8 weeks in duration * participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period * participants with a 17-item hamilton depression rating scale (ham-d17) total score ≥ 18 at the baseline visit for the prospective treatment phase. exclusion criteria: * lack of prior treatment with an antidepressant during the current depressive episode * participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode. * participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode * participants with epilepsy or significant history of seizure disorders * participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder * participants who have received electroconvulsive therapy (ect) in the last 10 years.

Keywords: major depressive disorder mdd depression
safety study of apixaban in recent acute coronary syndrome

Conditions: Acute Coronary Syndrome (ACS)

Summary: the purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.


Eligibility criteria:
key inclusion criteria: * recent (\< = 7 days) acute coronary syndrome (acs). * clinically stable on optimal treatment key exclusion criteria: * high bleeding risk. * ongoing anticoagulant use. * need for chronic (\>3 months) daily nonsteroidal anti-inflammatory drug (nsaid) or chronic high dose acetylsalicylic acid (asa) use (\>325 mg/day
evaluation of an app based on artificial intelligence for pain assessment in pediatric department

Conditions: C23.888.592.612.081

Summary: accurate assessment of pain in pediatric department is challenging. however, recent publications highlight that children do not receive optimal pain management, particularly in emergency departments. an artificial intelligence-based tool could help physicians to optimize analgesia use.

acute pain is the reason that the majority of patients present to the emergency department. multiple studies conducted over many years have demonstrated that pain is poorly managed in the emergency department. this phenomenon has been referred to in the medical literature as "oligoanalgesia.". morever, untreated pain can have short and long term effects in pediatric population, including sensitisation to pain episodes in later life and can affects the neurodevelopment of the child. the generally accepted standard for pain assessment is self-reported; however, in preverbal children who cannot communicate their pain, age-appropriate behavioural or observational pain assessment tools are recommended. because children are not always able to voice their feelings, they completely depend on their caregiving team for the interpretation and management of their pain and discomfort. thus, accurately validated scales to assess pain levels are crucial. in france, the evendol is the most used widely scale. the evendol scale (from the french evaluation enfant douleur) is used to evaluate pain in children in any situation covering a wider age group than other pain scales (birth up to seven years). despite a large number of scales with a variety of psychometric properties having been published in the last decades, to date, there is no criterion standard when considering the assessment of pain. as a result, children continue to be suffered pain without adequate pain management. international guidelines incorporate the need for prompt recognition of pain. artificial intelligence (ai) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. ai in this field can be used to support clinician decision making, allow curiosity-driven care, remove the need to complete mundane tasks, improve communication, and facilitate collaboration. evaluation of the face is central to all observational pain assessment tools, as the face is highly accessible and facial expressions are considered the most encodable feature of pain therefore.the investigators aim to develop, validate and asses a system based on digital face recognitation for pain assessment in the children's department.

Eligibility criteria:
inclusion criteria: * child under 18 * informed and written consent of a parent or guardian (only 1 accompanying person allowed). exclusion criteria: * language barrier. * refusal to participate by parents/children * sign of collapsus, or in serious clinical condition (stage i or ii) requiring absolute emergency care, * delayed mental or staturo-ponderal development * facial injury or wound, presence of a bandage on the face, pre-existing facial deformity
chart review study to describe the clinical profile of idiopathic pulmonary fibrosis (ipf) patients treated with nintedanib (ofev®) in real-world practice in spain

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the present study has been designed to characterize ipf patients treated with nintedanib (ofev®), at time of treatment initiation, with respect to their clinical profile based on real-world data from january 2016 in spanish pulmonology services.


Eligibility criteria:
inclusion criteria: * the patient is at least 18 years old * the patient has ipf diagnosis according to most recent ats/ers/jrs/alat ipf guideline for diagnosis and management \[5\] * the patient newly initiated treatment with nintedanib (ofev®) since 01 january 2016 up to end of data collection date, according to the approved local summary of product characteristics (smpc) exclusion criteria: - patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.
developing microbials to fight extended-spectrum beta-lactamase (esbl)-producing escherichia coli

Conditions: Extended Spectrum Beta Lactamases (ESBL) E. Coli

Summary: this study is to identify and isolate well-defined microbials (non-esbl e. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with esbl e. coli.

antibiotic resistance is a severe threat to contemporary medicine. effective approaches to fight multi-drug resistant pathogenic bacteria are needed. this clinical observational study is to investigate whether express extended spectrum beta lactamases (esbl) e. coli colonizing the human gut can be out-competed by other, ideally pan-sensitive strains (non-esbl e. coli).

Eligibility criteria:
inclusion criteria: * travelling to southeast asia (india, bhutan, nepal, bangladesh, myanmar, thailand, laos, cambodia, vietnam) for a maximum of 4 weeks. exclusion criteria: * other travelling destinations than mentioned above * antibiotic use at the first sampling time * participants who are not colonized will serve as a control group for microbiome comparison

Keywords: antibiotic resistance pan-sensitive strains (non-esbl e. coli) multidrug resistant e. coli strains esbl e. coli displacement multidrug resistant enterobacteriaceae
establishment of the national registry for inherited retinal dystrophy in iran

Conditions: Inherited Retinal Dystrophy Primarily Involving Sensory Retina; Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium

Summary: purpose: to establish of the national inherited retinal dystrophy registry (irdr) in iran. methods: this study is a community-based participatory research that is approved by the ministry of health and medical education of iran in 2016. to provide the minimum data set (mds), several focus group meetings will be held with participation of the faculty members of the ophthalmic research center affiliated to shahid beheshti university of medical sciences (sbmu). final mds will be presented to the software engineering team to develop a web-based software. in the pilot phase, software will be set up in two referral centers including labbafinejad medical center (tehran) and alzahra eye hospital (zahedan) to discover the possible drawbacks. final diagnosis will be made based on both clinical manifestations as well as genetic findings.the steering committee meetings are planned to be held each year with the presence of delegates of all centers.


Eligibility criteria:
inclusion criteria: * patients with a definite diagnosis of ird diagnoses based on clinical examinations and genetic testing. exclusion criteria: * individuals who have a suspected diagnosis of ird disease
telemonitoring impact by the aptelecare software in dialysis patient

Conditions: Chronic Renal Failure; Dialysis Related Complication

Summary: the investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of aptelecare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. for this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of telemonitoring (january 2012 and december 2013 inclusive - group 1) with patients data who have benefited from this application (between august 2016 and july 2018).


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) with no age limit; * patients receiving peritoneal dialysis on the investigation center between 2012 and 2014 (group1) and between 2016 and 2018 (group 2); * patient information in this retrospective study; exclusion criteria: * patients who have started a peritoneal dialysis program before the periods of investigation; * patients who have been equipped with aptelecare during the dialysis program; * subject under guardianship, curators or safeguard of justice; * patient not affiliated to a french social protection;

Keywords: home peritoneal dialysis
the screening and analysis of plasma biomarkers in irreversible pah-chd

Conditions: Hypertension,Pulmonary

Summary: the purpose of this study is to analyse the sensitivity and specificity of circulating endothelial cells to predict irreversible pulmonary arterial hypertension associated with congenital heart disease.

predict to recruit 100 patients with pulmonary arterial hypertension (pah)associated with chd，under the commitment of the children's parents，take 3-4ml central venous blood before the corrective surgery，then calculate the number of the circulating endothelial cells by flow cytometer and detect the expression of micro rnas to screen out the biomarker，through the 6 months follow-up, separated the reversible and irreversible pah,then to carry on the statistics.

Eligibility criteria:
inclusion criteria: * only those patients with systolic pap (spap) \>65mmhg before surgery were included. exclusion criteria: * patients with trisomy 21 (down syndrome) were not included

Keywords: biomarkers，pulmonary arterial hypertension
shear wave elastography technology to evaluate the efficacy of esw in the treatment of patients with chronic plantar fasciitis

Conditions: Chronic Plantar Fasciitis

Summary: inflammation of the plantar fascia is called plantar fasciitis and is common in active or overweight individuals. it can be treated conservatively or surgically. extracorporeal shock wave therapy has shown significant efficacy in the treatment of plantar fasciitis. repeated chronic inflammation of the plantar fascia may lead to fibrous edema, thickening and even calcification in the fascia, resulting in thickening of the plantar fascia in patients with chronic plantar fasciitis and affecting the mechanical properties of the plantar fascia (changes in elastic modulus) ). previous studies rarely involved changes in the elasticity of the plantar fascia before and after extracorporeal shock wave treatment.


Eligibility criteria:
inclusion criteria: 1. pain at the proximal calcaneal stop of the plantar fascia 2. the pain is severe when waking up in the morning or standing and walking after sitting for a long time, and it is slightly relieved after activities, and it will be aggravated after long walking or standing for a long time 3. pain time\> 3 months 4. visual scoring scale (vas)\>4 5. the pain is tingling, sore, or burning, etc 6. there is or no tender point at the bottom of the arch of the foot 7. the patient has not undergone corticosteroid injection therapy or shock wave therapy or surgery 8. x-ray confirmed no calcaneal spurs 9. the patient agrees to participate in this study exclusion criteria: 1. suffering from calcaneal stress fracture, atrophy of fat pad, compression of the little toe abductor nerve (baxter's nerve), tarsal tunnel syndrome, sciatica, bone or soft tissue tumor, rheumatism or rheumatoid arthritis, rigidity those with spondylitis and infection 2. those who disagree with and do not understand the treatment methods or methods of the experiment 3. those with mental disorders

Keywords: extracorporeal shock wave chronic plantar fasciitis elastic modulus
development of a mobile system for self-management of schizophrenia (sos)

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this 2-arm clinical trial piloted a mobile self-management of schizophrenia (sos) system that administers interventions targeting persistent symptoms of psychosis, social dysfunction, and medication adherence. researchers compared an intervention arm using the sos system and an arm receiving treatment as usual on the outcomes of change in severity of psychotic symptoms and change in social functioning.


Eligibility criteria:
inclusion criteria: * dsm-iv (diagnostic and statistical manual iv) criteria for schizophrenia or schizoaffective disorder based on a chart diagnosis; * 18 years or older; * prescribed oral antipsychotic medication; and * a rating of "3" or lower on one of the three items which comprise the domination by symptoms factor from the recovery assessment scale, indicating patient-rated need for illness self-management exclusion criteria: * hearing, vision, or motor impairment that make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening); and * english reading level below 4th grade (determined using the wide range achievement test - 4th edition)

Keywords: schizophrenia schizoaffective disorder self management of schizophrenia sos serious mental illness psychosis social dysfunction medication adherence mobile application ehealth e-health health technology mobile health m-health electronic health
differential diagnosis and risk stratification in patients with suspected nsteacs

Conditions: Non ST Segment Elevation Acute Coronary Syndrome

Summary: to evaluate possibilities of rapid differential diagnosis and risk stratification in patients urgently admitted to the ccu with a suspected acute coronary syndrome without persistent st-segment elevation (nsteacs).

single centre prospective non-randomised non-comparative study of patients delivered by ambulance and admitted to the ccu with suspected nsteacs. aims of this study are: 1. to characterize the contingent of patients admitted to the ccu with suspected nsteacs. 2. to evaluate possibilities of fast differential diagnosis and risk stratification in patients admitted to the ccu with suspected nsteacs using clinical data, ecg, biomarker levels (hstn, nt-probnp, hscpr, cardiac fabp) as well as heart, adapt, edacs, t-macs, grace, action and timi scores. 3. to evaluate the correlation between clinical data, ecg, biomarker levels (hstn, nt-probnp, hscpr, cardiac fabp) as well as heart, adapt, edacs, t-macs, grace, action and timi scores with presence and severity of coronary atherosclerosis in patients admitted to the ccu (intensive care unit) with suspected nsteacs.

Eligibility criteria:
inclusion criteria: 1. delivered by ambulance to the ccu with suspected diagnosis "acute coronary syndrome (acs)". 2. signed informed consent. exclusion criteria: 1. acs with persistent st-segment elevation. 2. moribund; extremely severe condition on admission with a potentially unfavourable prognosis (cardiogenic shock, coma, cardiac arrest, an urgent need for mechanical ventilation). 3. overt non-cardiac cause of clinical manifestations at the time of admission (bleeding, pulmonary embolism, aortic dissection, stroke).

Keywords: non st segment elevation acute coronary syndrome diagnosis prognosis
prospective evaluation of proteinuria and renal function in non-diabetic patients with progressive renal disease

Conditions: Hyperlipidemia

Summary: the purpose of this study is to evaluate the effects of crestor (rosuvastatin) and (lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * hyperlipidemia * urinary protein exclusion criteria: * previous rosuvastatin treatment \< 6 months prior to visit 1 * statin intolerance * severe hypertension * diabetes

Keywords: hyperlipidemia proteinuria diabetes mellitus
chemosensitivity during phases of the menstrual cycle in breast cancer patients

Conditions: Breast Cancer

Summary: this study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients


Eligibility criteria:
inclusion criteria: * women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment. * patients with stage i-iii disease, patient with locoregional recurrence who have not been treated with chemotherapy before. , * aged \< 60 years * women having a (regular) physiological menstrual cycle * patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy * patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy) * signed written informed consent exclusion criteria: * current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as: * oral contraception (oac) * hormonal intra-uterine device (iud, mirena) * no ovarian function suppression to preserve fertility * other forms of hormonal contraception, including but not limited to: nuva-ring, implanon, prikpil * currently pregnant and / or breast feeding. in case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception. - active other malignancy * ivf-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment

Keywords: triple negative tumor stage i - iii disease starting neo adjuvant treatment regular physiological menstrual cycle (premenopausal)
study of tissue samples from patients with glioma or other brain tumors

Conditions: Central Nervous System Lymphoma

Summary: rationale: studying the genes expressed in samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at tissue samples from patients with glioma or other brain tumors.

objectives: primary * to better understand the pathophysiology of gliomas and identify molecular markers that may predict prognosis and progression or that could identify new therapeutic approaches. secondary * to compare gene expression profiles, in terms of response to treatment, and attempt to isolate subgroups of patients with objective response to certain types of chemotherapy or radiotherapy. outline: this is a multicenter study. biological samples are collected from patients at time of surgery for diagnostic and/or treatment purposes.

Eligibility criteria:
inclusion histologically confirmed glioma of any grade or rare primary brain tumor no urgent situation no known or suspected active infection must not be deprived of liberty or protected by law not pregnant or nursing exclusion : no concurrent participation in other trials that require a period of exclusion

Keywords: adult anaplastic astrocytoma adult diffuse astrocytoma adult glioblastoma adult giant cell glioblastoma adult gliosarcoma adult pilocytic astrocytoma adult pineal gland astrocytoma adult subependymal giant cell astrocytoma adult brain stem glioma adult choroid plexus tumor adult craniopharyngioma adult ependymoblastoma adult medulloblastoma adult supratentorial primitive neuroectodermal tumor (pnet) adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma meningeal melanocytoma adult meningeal hemangiopericytoma adult grade i meningioma adult grade ii meningioma adult anaplastic meningioma adult papillary meningioma adult anaplastic oligodendroglioma adult oligodendroglioma adult pineoblastoma adult pineocytoma adult mixed glioma recurrent adult brain tumor
determinants of function and clinically important outcomes in proximal humerus fractures

Conditions: Humeral Fractures, Proximal

Summary: the proposed project will be a multi-centre, prospective observational study to determine the prognosis and determinants of functional outcomes of patients with proximal humerus fractures. approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.


Eligibility criteria:
inclusion criteria: males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture exclusion criteria: pathologic fractures patients likely to be lost before completing follow-up patients who do not provide consent patients who do not speak english and who do not have a translator that will be available during consent discussion and at each follow-up.